Clinical Evaluation • Regulatory Affairs
Duration: 9 months • Role: Clinical & Regulatory Reviewer
Reviewing a Clinical Evaluation Report (CER) showed that the template alone was not enough: it only holds up cross-functionally if the people writing into it (Regulatory, Clinical, Quality) are trained on the same expectations, so the template and the training needed to ship together.
A Clinical Evaluation Report is a cross-functional document, but each function had been contributing to it without a shared understanding of what "complete" and "traceable" meant. The template needed a companion training to keep future CER cycles consistent.
Reviewed the CER against current clinical literature, intended use, and applicable MDR/ISO 13485 requirements, checking each section for completeness and traceability to supporting evidence.
Delivered a CER template alongside a QMS training presentation, giving the cross-functional team a shared reference for future clinical evaluation cycles.
A CER template only works cross-functionally if the people writing into it (Regulatory, Clinical, Quality) are trained on the same expectations, so the template and the training have to ship together.
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